Quality Management System Expert

• International company
• Medical devices

Our client is an international company specialized in medical devices.

Description

• Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels.
• Work collaboratively and support process owners in reviewing, structuring, and documenting their functional new or improved processes.
• Analyze existing processes and ensure integration and consistency across shared, linked, and cross-functionally dependent processes.
• Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR and other applicable regulations.
• Actively monitor effectiveness of the quality management system and propose and execute improvement projects.
• Lead complex quality initiatives (e.g. CAPA, process improvements, new processes, gap analyses, system integrations), make recommendations, develop and execute plans.
• Plan and conduct internal audits by participating and leading internal audits, follow up on the findings with auditee through effective closure, and present the data for trending.
• Support electronic QMS transition and take ownership of the software tools including QMS documentation and change control.

Profile

• Degree in Engineering, Scientific.
• 7+ years of quality-related system experience in a medical device company developing medical devices.
• Excellent technical writing, proofing, and language (grammar and spelling) skills with strict attention to detail.
• Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR).
• Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills.
• Advanced problem-solving, organizational, analytical and critical thinking skills.
• Certified lead auditor.
• Electronic QMS experience is preferred.
• Excellent command of English language.

Job Offer

Great opportunity to join an amazing team and work on challenging projects.